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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

Grundmann 1987.

Methods
  • Study design: parallel RCT

  • Study duration: September 1983 to November 1985

  • Study follow‐up: all followed to November 1986

Participants
  • Country: Germany

  • Setting: single centre

  • Inclusion criteria: 1st DD kidney transplant recipients

  • Number: treatment group 1 (50); treatment group 2 (50)

  • Mean age ± SD (years): treatment group 1 (38.5 ± 10.8); treatment group 2 (38.7 ± 12.0)

  • Sex ratio (M/F): treatment group 1 (1.9/1); treatment group 2 (1.6/1)

  • Exclusion criteria: not reported

Interventions Treatment group 1
  • ALG: 14 days; dose 5 mL/kg/d to max of 30 mL/d via CVC continuous IV infusion

  • PRED: 250 mg day 1, taper by 25 mg/d till 100 mg, then taper by 5 mg/d to 5 to 10 mg/d achieved

  • AZA: max 3 mg/kg/d, depending on WCC platelet count

  • AZA and ALG switched to CSA at day 14 or earlier if unable to tolerate complete ALG course

  • CSA: 8 mg/kg (2 doses), aim for trough levels of 300 ng/mL


Treatment group 2
  • ALG, AZA and steroids: given for 7 days post‐op; thereafter ALG and AZA switched to CSA

Outcomes
  • Death

  • Graft loss

  • DGF

  • Acute rejection

  • Infection

  • Tolerability of treatment

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not specified if diagnosis of acute rejection was biopsy proven or clinical
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patient outcome data reported
Selective reporting (reporting bias) Unclear risk Unsure why acute rejection not reported beyond 3 weeks if there were any incidences of any other side effects such as malignancy/PTLD
Other bias Unclear risk Funding source not reported